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Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors

NCT07675070 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-06-30

No results posted yet for this study

Summary

This is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Amitzo® in Iranian patients with grade III and IV glioma tumors. No control group is considered in the study design. The primary objective is to evaluate the incidence of hepatic injury in patients with grade III and IV glioma tumors, treated with Amitzo®.

Conditions

Interventions

DRUG

temozolomide

Temozolomide (Amitzo®, NanoAlvand), during the first five days of every 28-day cycle.

Sponsors & Collaborators

  • NanoAlvand

    lead INDUSTRY

Principal Investigators

  • mohadese shahin, Assistant Professor · Iran University of Medical Sciences

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-22
Primary Completion
2026-09-30
Completion
2026-11-30

Countries

  • Iran

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675070 on ClinicalTrials.gov